Prostate cancer (PCa) is the second leading cause of male cancer deaths in the U.S., and although the disease can be managed or treated in many ways, clinicians lack suitable scanning tools for diagnosing and tracking PCa. Conventional magnetic resonance imaging (MRI) at 1.5 tesla and above is used increasingly for the detection, diagnosis, and staging of cancer. In the case of prostate cancer, however, conventional MRI does not provide sufficient specificity for detection of prostate tumors, even when used with a contrast agent. To take advantage of the enhanced T1 (longitudinal relaxation time)contrast available at low magnetic fields, a novel ultralow field MRI (ULF MRI) device has been developed at Lawrence Berkely National Laboratory (LBNL) that acquires MR images at microtesla fields, comparable to the Earth's field, and uses a Superconducting QUantum Interference Device (SQUID) to enhance the signal-to-noise ratio. Using this prototype device, preliminary data on surgically removed prostate specimens indicate that there is significantly enhanced T1 contrast between prostate tumors and healthy prostate tissue at microtelsa fields. However, although we expect T1 contrast to persist in vivo, the degree of contrast is unknown, and, as currently constructed, the ULF MRI device is not suitable for imaging the prostates of subjects in vivo. A team of physicists and engineers from High Precision Devices proposes to work with the developers of the ULF MRI at LBNL, along with consultants including Quantum Design, a leader in SQUID technology, and the Radiology Department at the University of California San Francisco Medical Center, in a Phase I project to validate that this technology is ready for further research and commercial development. The project will have two Specific Aims. The first will be to design, construct, and verify an ULF MRI device that is safe and configured for obtaining a prostate scan in vivo. The second is to use this device in a study that will image volunteer subjects known to have prostate cancer, and compare those images to a state-of-the-art multiparametric set of 3T images obtained at UCSF to validate that the technology can move to Phase II. Consequently, the overall goal of this multi-phase SBIR project is to develop, validate, fully prototype and commercialize this ULF MRI device. This device would potentially be less expensive and more open than conventional MRI scanners, and could significantly impact the diagnosis and staging of prostate cancer. Possible applications include 1) imaging the prostate following a positive PSA test to determine the location and extent of the cancer;2) serial imaging to determine the progression of tumors during treatment or active surveillance;3) more accurate mapping of the location of tumors to guide biopsy;and 4) in situ monitoring of focal therapies, such as placement of the seeds during brachytherapy. PUBLIC HEALTH RELEVANCE: The American Cancer Society estimates that nearly 200,000 males will be newly diagnosed with prostate cancer in the U.S. this year, and currently there is no clinically proven scanning technology that can image prostate tumors and track their progression in an affordable and accurate manner. Scientists at the Lawrence Berkeley National Laboratory have built and tested an MRI device that uses very low magnetic fields compared to conventional MRI systems, and they have used it to differentiate cancerous and healthy tissue in specimens of surgically removed prostates. The High Precision Devices R&D team proposes to re-construct the device in a configuration able to scan the prostate safely, and to image the prostates of volunteer subjects known to have cancer to establish that the technique is viable and should be pursued into clinical trials.